What is the point to performing randomization and blinding? What is more blind than this double or even triple blind? What is randomization and why is it important?
Step 1: Collect multiple placebo treated cohorts from similarly captured criteria and check their concordance.
Note: Criteria need not be exact as it will be pooled to create diversity.
Step 2: Group cohorts into a super cohort of randomized placebo patients
Step 2b: Randomly sample from super cohort and test sampling vs super cohort for internal validation
Step 3: Externally validate super cohort against two failed treatment groups
Step 4: Break trial patients and super cohort patients into groups based on risk factor buckets and determine their relative weighting.
Step 5: Retain trial placebo non-crossovers for internal validation of sampled cohort.
Step 6: Add original remaining placebo to matched, sampled, validated (internally - externally x2 - internally once again) cohort for new comparison cohort
Step 7: Compare original randomly selected treatment arm to randomly captured, blindly selected, placebo matched cohort
Step 8: Repeat process for sensitivity analysis
How does this sound to you colleague, regulator, fill in the blank?
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